Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-12

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Diabetes Self-management Education on Glycaemic Control in Patients With T2DM

NCT07149311

Diabete Type 2

COMPLETED NA

Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus

NCT06897618

Diabetes Mellitus Diabete Type 2

RECRUITING NA

Social Support Intervention for Self-management of Type 2 Diabetes Mellitus

NCT04491253

Diabetes Mellitus, Type 2

COMPLETED NA

The Effect of a Diabetes Self-management Coaching Program for Type 2 Diabetes Patients in the Ethiopian PC.

NCT05336019

Type 2 Diabetes Diabetes Mellitus, Type 2

COMPLETED NA

A Randomized Trial of an Intensive Education Intervention Using a Network of Involved Diabetic Patients (Peer Educators) to Improve Glycemic Control of Type 2 Diabetic Patients

NCT01485913

Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Patient Engagement Patient Education

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Behavioral: Diabetes Self-management behaviors

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetes Self-Management Behaviors

Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks.

Group Type EXPERIMENTAL

Diabetes Self-Management Behaviors

Intervention Type BEHAVIORAL

The intervention is to be delivered by an interventionist.

Usual Type 2 Diabetes Care

The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diabetes Self-Management Behaviors

The intervention is to be delivered by an interventionist.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Self-described Haitian immigrant aged 21 and older
* Known diagnosis of type 2 diabetes for at least one year
* Have lived in the US for at least one year
* Have an HbA1c of 7.5%
* Willing and able to participate in an individual interview